Core Viewpoint - NEFECON (Budesonide Delayed-Release Capsules) has been included in the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" in China, marking it as the only IgA nephropathy treatment recommended by both domestic and international guidelines, solidifying its position as a cornerstone therapy for IgA nephropathy patients [1][3]. Group 1: Treatment Guidelines - The guidelines recommend initiating treatment for patients with proteinuria ≥0.5 g/d and suggest kidney biopsy, with treatment goals aimed at reducing proteinuria to <0.5 g/d and maintaining an estimated glomerular filtration rate (eGFR) decline of <1 ml/min annually [2]. - New monitoring for hematuria has been introduced, and interventions targeting immune damage, including reducing pathogenic IgA, are emphasized [2]. - The guidelines advocate for early, cause-targeted, and comprehensive treatment strategies for IgA nephropathy patients, with NEFECON as the preferred treatment option [2][3]. Group 2: Clinical Significance - The inclusion of NEFECON in the guidelines is seen as a significant advancement for clinical practice in China, providing a scientifically backed treatment option for IgA nephropathy patients [3]. - NEFECON is the first and only IgA nephropathy treatment fully approved in China, the US, and Europe, demonstrating significant clinical advantages such as delaying eGFR decline and reducing proteinuria [3][5]. - The NefIgArd Phase III clinical trial showed that NEFECON significantly reduced the risk of kidney function decline by 50% compared to placebo, with a 66% reduction in the Chinese population, potentially delaying the need for dialysis or kidney transplant by 12.8 years [5].
云顶新耀(01952)耐赋康®被纳入《中国成人IgA肾病及IgA血管炎临床实践指南(预审版本)》